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Pharmacovigilance System in Lebanon

Pharmacovigilance System in Lebanon
One of the core functions of the Lebanese Ministry of Public Health (MoPH) is to safeguard the Quality, Safety and Efficacy of medical products (medicines, vaccines, biological and medical devices) at the national level. This task is carried out by the Quality Assurance of Pharmaceutical Products (QAPP) Program at MoPH, directed by Dr. Rita Karam which aims, in specific, to reinforce the implementation of quality standards relating to the safety of pharmaceutical products and to ensure that drugs reach the patient in a safe, effective and acceptable manner.  The enhancement of patient safety is achieved by the project on the implementation of a National Pharmacovigilance (PV) System.  Within the framework of the above mentioned project, the MoPH QAPP program developed a national system for spontaneous reporting of adverse events, and designated the PV Center at the Faculty of Pharmacy at the Lebanese University (LU). http://phcvg-lebanon.com/index.php/en/phcvg-n/

I- Pharmacovigilance Definition

PV is defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of Adverse Events (AEs) or any other medicine related problem. Its aims are to enhance patient care and patient safety and to support public health programmes by providing reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and vaccines. PV addresses AEs of medicines, medicine errors, counterfeit/substandard medicines, lack of efficacy, abuse and misuse of medicines, and interaction of medicines.

II- Importance of Pharmacovigilance

Medicines and vaccines have changed the way in which diseases are prevented and treated.  In spite of their benefits, medical products have unexpected effects. Some of these effects are unfavorable, ranging in severity, seriousness and frequency within the intended population.  While medicines and vaccines are studied in well controlled clinical trials and reviewed by regulatory authorities with the aim of ensuring benefits outweigh risks, some adverse effects (AEs) are observed only once the product is authorized by regulators and used by a larger population in ‘real world conditions’, including special populations such as children, pregnant women and elderly.  It is therefore critical that medical products continue to be monitored for their effectiveness and safety post release. In practice this means having in place a well-functioning PV system.

Improper monitoring of medicines and vaccines can lead to catastrophic consequences. In some countries, the AEs are ranked 4th to 6th on the mortality scale. The total percentage of hospital admissions due to such events is an average between 10-20%. Some healthcare systems spend around 15-20% of their budget on medicine-related AEs which adds up to a high economic expenditure. In response to these figures, every country must strictly adhere to the application of PV.  

What are the Advantages of Pharmacovigilance System? It:
  • Reduces medicine/vaccine-related problems leading to better treatment outcome
  • Improves the quality of care offered to patients
  • Improves patients confidence in professional practice
  • Is a cost effective method of monitoring the safety of medicinal products throughout its lifetime
  • Includes AEs reporting system which is the primary method of data collection used in most countries as it is an easy and fast way to submit an urgent health related issues
  • Provides feedback information on medicine/vaccine-related problems reported nationally and internationally 
 
III- About Pharmacovigilance

Pharmacovigilance System Mission
Detecting, assessing, understanding and preventing AEs
.
Pharmacovigilance System Vision
Paddling in the same direction of the PV international community to achieve safer use of medicines worldwide

Pharmacovigilance System Values

 
 
Stakeholders of the Pharmacovigilance System in Lebanon

The PV System in Lebanon is comprehensive and includes many stakeholders:
  • The government is responsible for providing all the support needed for the national PV System through well-established national policy and action plan.
  • The QAPPP at the MoPH, that is responsible for the implementation of quality standards related to the safety of pharmaceutical products, aimed at ensuring that medicines reach the patient in a safe, effective and acceptable manner. The QAPPP oversees the implementation of the PV System.
  • The  Lebanese National Pharmacovigilance Center ( LNPVC) at the Faculty of Pharmacy - Lebanese University : http://phcvg-lebanon.com/index.php/en/phcvg-n/
  • The WHO-PIDM which is the forum where member states can collaborate in PV. The PIDM is responsible for policy issues, while the other partner, the Uppsala Monitoring Center (UMC) conducts operations.
  • Other parties (e.g., Marketing Authorization Holder, Health-Care Providers, Public Health Programs, Expanded Program for Immunization (EPI) and Primary Health Care Centers and patients/consumers) responsible for reporting AEs which collaborate as main stakeholder to the PV System through submitting Individual Case Study Reports (ICSRs) to the LNPVC. 
 
IV- Steps for the Implementation of Pharmacovigilance System in Lebanon: Regulations

Because of the seriousness of the situation, the MoPH decided to integrate strategies and regulations for medicines safety monitoring which included implementing the National PV System and the National Policy on the Safe and Rational Use of medicines and vaccines.
In this regard, the following chronological regulatory framework is considered to be the core building blocks related to the implementation of a PV system in Lebanon:
 
  1. Ministerial Decree No.13370 (2004)
A Ministerial Decree No.13370 issued in 10/09/2004 from the Ministry of Education stated the creation of the Center for AEs of Drugs’ Monitoring in the Faculty of Pharmacy at the Lebanese University.
Ministerial Decree No.13370 (2004)
 
  1. Ministerial Resolution No. 1636 (2013)
The MoPH released several mandatory instruments including: Ministerial Resolution No. 1636 issued in 19/02/2013 to establish a committee at the QAPPP to examine AEs. Its responsibility covers the collection of AE-related data, review and evaluating this information, and communicating with the Center for AEs of Drugs’ Monitoring. Every AE collected and evaluated is then reported back to the Technical Committee (TC) of medicines at MoPH for decision making.
Minister's Decision No.1636 of 9/10/2013
 
  1. Collaborative Agreement (2016)
A collaborative agreement between the Lebanese University and MoPH dated 24/02/2016 authorized the Center for Drugs Monitoring of Advers Events at the Faculty of Pharmacy of the Lebanese University to function officially as National Pharmacovigilance Center.
 
  1. A Strategic and Operational Plan (2016-2020)
A strategic and operational plan for a period of 5 years (2016-2020) was drafted for the MoPH in 2016. The main goals of the plan include upgrading the hospital accreditation and licensing systems as well as establishing Pharmacovigilance and post-marketing surveillance systems. Through the MoPH, QAPP applies for membership to the WHO-PIDM and Lebanon became an Associate Member in July 2018.
Strategic Plan for the Medium Term (2016 to 2020)
 
  1. PV Strategic Plan and Operational Plan (2020-2025)
A PV system strategic plan and an operational plan for the upcoming 5 years 2020-2025 was drafted and it details all the activities, objectives, regulations, departments, responsible personnel, partners, collaborators, timescale, and indicators.
 
  1. Ministerial Resolution No. 1438/1 (2019)
Related to work mechanisms for the PV project in Lebanon and assigns Dr. Rita Karam as PV coordinator between the MoPH, WHO and LNPVC
           Minister's Decision No.1438 of 25/7/2019
 
  1. Ministerial Resolution No. 427/1 (2020)
The resolution is related to the Procedure for Reporting Adverse Drug Reactions Related   to COVID-19 treatments.
Minister's Decision No.427 of 14/4/2020
 
  1. Ministerial Resolution No. 556/1 (2020)
The Regulation states the procedure for Reporting Adverse Drug Events related to the COVID-19 treatment by the responsible parties of Pharmaceutical Products and Drug Distributors
Minister's Decision No.556 of 28/5/2020
 
  1. Minister's Decision No.180/1 (2021)
 
  1. Minister's Decision No.181/1 (2021)
 
  1. Memorandum No.8 (2021)
    Minister's Memo No.8 of 8/2/2021
 
  1. Letter related to the Nomination of Hospital Pharmacovigilance Focal Points
V- Reporting of Adverse Events for Medicines and Vaccines
 
  Email address
            phvg.phar@ul.edu.lb 
  Electronic Reporting: e reporting
             https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=LB
 
Quality Assurance of Pharmaceutical Products Program: 01-830254  01-830255
 
Lebanese National Pharmacovigilance Center: 05-463652


Pharmacovigilance Team

Dr. Rita Karam: Head of National Pharmacovigilance Program
Dr. Abeer Zeitoun: Senior Clinical and Technical Manager at the Pharmacovigilance Program
Dr. Myriam Watfa: Pharmacovigilance Program Consultant
Dr. Katia Iskandar, Pharmacovigilance Consultant
Dr. Sarah Rida El Sayed: National Pharmacovigilance Officer
Dr. Aya Ibrahim: National Pharmacovigilance Officer


For further information please visit the following link:
https://www.who.int/teams/regulation-prequalification/pharmacovigilance
 
Contact us:

Telephone: +961-1-830300 Ext: 254/5
Email: pv@moph.gov.lb
 
Lebanese National Pharmacovigilance Program News letter
 
 
Pharmacovigilance Activities
Second Oman Pharmacovigilance Symposium



Webinar Briefing- June 2022







Capacity Building- November 2021








 
 
Pharmacovigilance News


1st Annual Lebanese Pharmacovigilance Conference- Briefing


Medicines Safety Takes Root in Lebanon


A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study


Vaccination Process Evaluation at COVID-19 Vaccination Centers in Lebanon: A National Study


Implementation of a PV System in Lebanon Review article


Launching Event- September 2022


ISQua Webinar Briefing- September 2022


TV Interview Briefing- September 2022

The Pharmacovigilance training sessions, organized by Dr. Rita Karam and Dr. Myriam Watfa took place four times between the time period of 26 February 2021 until the 19th of March 2021. The presentations were run by Dr. Karam, Dr. Katia Iskandar, Dr. Jihane Howayek, Dr. Hanine Abbas and Dr. Watfa and moderated by both Dr. Karam and Dr. Issam Kassab. The webinars' participants were based on the selection of healthcare professionals who work in both public and private sectors. 

Based on the organization, proceedings, outcome, and participants’ evaluation, it is judged that the webinars were a success.  
The organizers wish to acknowledge WHO represented by Dr. Omar Al Rifai for its support, the PV team for its dedication, and the participants for their willingness and input. 



Awareness Campaign for COVID-19 Vaccine


How to report adverse events folowing immunization by COVID-19 Vaccines
 
PharmacoVigilance in the context of COVID-19
The current COVID-19 pandemic presents unique challenges for pharmacovigilance. According to the CIOMS/WHO Working Group, Vaccine Pharma­co­vi­gilance is the science and activities relating to the: detection, assessment, understanding, communication of Adverse Event Following Immunization (AEFIs) and other Vaccine- or Immuni­zation-related issues, and prevention of untoward effects of the Vaccine or Immunization

According to WHO, an Adverse Event Following Immunization (AEFI) is any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.

The PharmacoVigilance Program at the MoPH is currently in charge of handling and processing all reported AEFI with the COVID-19 vaccines
 
Pharmacovigilance Alerts
  1. Medical Product Alert No. 1 2024 - Falsified (contaminated) USPEP PROPYLENE GLYCOL
  2. Medical Product Alert No 1/2023 - Substandard (contaminated) liquid dosage medicines identified in Region
  3. Medical Product Alert No 2/2023- TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%Manufactured by Galentic Pharma (India) Pvt. Ltd
  4. Medical Product Alert No 3/2023 - Falsified DEFITELIO (defibrotide sodium) identified in the WHO Regions of Europe and the Eastern Mediterranean
  5. Medical Product Alert No 4/2023 - Substandard (contaminated) syrup medicines identified in WHO Region of the Western Pacific
  6. Medical Product Alert No 5/2023 - Substandard (contaminated) syrup medicines identified in WHO Region of Africa
  7. Medical Product Alert No 6/2023 - Substandard (contaminated) syrup medicines identified in WHO Region of the Eastern Mediterranean
  8. Medical Product Alert No 7/2023 - Falsified DEFITELIO (defibrotide) identified in the WHO Regions of Europe and South-East Asia
  9. Medical Product Alert No 8/2023 - Substandard (contaminated) syrup and suspension medicines identified in the WHO Regions of the Americas Eastern Mediterranean South-East Asia and Western Pacific
  10. Medical Product Alert No 8/2022 - Substandard (contaminated) METHOTREXTM 50mg identified in the WHO Eastern Mediterranean region
 
 
Reports and Executive summaries in the Context of COVID-19
 
 
 
 
 
 
 
 
​
 
 
 
 
Reports and Executive summaries in the Context of Oral Cholera Vaccines
 
 
 
Public Awareness








                                    
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ATC Name B/G Ingredients Dosage Form Price
A06AA01 HUILE DE PARAFFINE G Liquid paraffin - Liquid 207,336 L.L
A06AB05 HUILE DE RICIN G Castor oil - Liquid 119,026 L.L
A06AB05 HUILE DE RICIN G Castor oil - Liquid 163,821 L.L
N02BE51 HUMACE PLUS G Paracetamol - 500mg, Aceclofenac (potassium) - 200mg Tablet 575,165 L.L
A10AB04 HUMALOG BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable suspension 2,411,838 L.L
A10AB04 HUMALOG KWIKPEN BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable solution 4,542,188 L.L
A10AB04 HUMALOG KWIKPEN BioTech Insulin lispro - 200IU/ml 200IU/ml Injectable solution 8,585,913 L.L
A10AD04 HUMALOG MIX 25 KWIKPEN BioTech Insulin lispro solution - 25%, Insulin lispro protamine suspension - 75% 100IU/ml Injectable suspension 4,542,188 L.L
A10AD04 HUMALOG MIX 50 KWIKPEN BioTech Insulin lispro solution - 50%, Insulin lispro protamine suspension - 50% 100IU/ml Injectable suspension 4,542,188 L.L
B05AA01 HUMAN ALBUMIN "OCTAPHARMA" 20% BioHuman Albumin human - 20% 20% Injectable solution 4,863,366 L.L
B05AA01 HUMAN ALBUMIN 20% SOLUTION BioHuman Albumin human - 20% 20% Injectable solution 4,055,430 L.L
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,055,430 L.L
N02BE51 HUMEX RHUME B Pseudoephedrine HCl (tablet) - 60mg, Paracetamol (tablet) - 500mg, Paracetamol (capsule) - 500mg, Chlorphenamine maleate (capsule) - 4mg Tablet, capsule 467,657 L.L
N02BE51 HUMEXLIB PARACETAMOL CHLORPHENAMINE B Paracetamol - 500mg, Chlorphenamine maleate - 4mg Capsule 598,010 L.L
M01AE03 HUMFINE G Ketoprofen - 100mg/2ml 100mg/2ml Injectable solution 3,514,148 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 33,860,031 L.L
L04AB04 HUMIRA BioTech Adalimumab - 80mg/0.8ml 80mg/0.8ml Injectable solution 33,860,031 L.L
A10AD01 HUMULIN 70/30 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A10AE01 HUMULIN N U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A10AB01 HUMULIN R U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 701,486 L.L
M09AX01 HYALGAN B Hyaluronic acid (sodium) - 20mg/2ml 20mg/2ml Injectable solution 3,407,985 L.L
D06BA51 HYALO4 PLUS G Hyaluronic acid (sodium) - 0.2%, Silver sulfadiazine - 1% Cream 466,313 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 862,440 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
H02AB09 HYDROCORTISON VUAB G Hydrocortisone hydrogenosuccinate - 100mg 100mg Injectable dry powder for solution 147,823 L.L
D07AA02 HYDROCORTISONE ACETATE G Hydrocortisone acetate - 1% 1% Cream 215,015 L.L
H02AB09 HYDROCORTISONE BIOCODEX LYOPHILISAT (FLACON) ET SOLUTION POUR USAGE PARENTERAL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable lyophilised powder for solution+diluent 139,760 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
H02AB09 HYDROCORTISONE ROUSSEL B Hydrocortisone - 10mg 10mg Tablet, scored 260,705 L.L
D07CA01 HYDROMYCINE G Neomycin sulfate - 0.005g/g, Hydrocortisone acetate - 0.01g/g Cream 238,052 L.L
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